AsthmaPhase 4NCT01985789
Anti-histamines and Methacholine Challenges.
A Phase 4 study testing Diphenhydramine, cetirizine and desloratadine in people with Asthma, run by Don Cockcroft at 1 site in Canada.
Trial summary
The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Diphenhydramine, cetirizine and desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted
- Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less
- No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study
- No significant medical co-morbidities
- allergy
Who cannot join
- pregnant or breastfeeding females
- unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.
- Conditions
- Asthma
- Being tested
- Diphenhydramine, cetirizine, desloratadine, placebo
- Keywords
- airway hyperresponsiveness
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenhydramineDrug
cetirizineDrug
desloratadineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| diphenhydramine | Active comparator | 50mg dose given as two 25mg capsules Receives: Drug: Diphenhydramine |
| cetirizine | Active comparator | 10mg dose given as 1 10mg capsule and 1 placebo capsule Receives: Drug: cetirizine |
| desloratadine | Active comparator | 5mg dose given as 1 5mg capsule and 1 placebo capsule Receives: Drug: desloratadine |
| placebo | Placebo comparator | given as 2 placebo capsules Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in methacholine pc20
Measured: change from baseline (pre dose) at 2 hours (post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Don Cockcroft
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Donald W Cockcroft, MD, Principal investigator, University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985789
- Sponsor's protocol ID
- PHPY2013/14
- Status last verified
- Apr 2015
- First submitted
- 31 Oct 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
- ClinicalTrials.gov ID
- NCT01985789
- Acronym / sponsor ID
- PHPY2013/14
- Conditions
- Asthma
- Keywords
- airway hyperresponsiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Don CockcroftUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diphenhydramine | Active comparator | Drug: Diphenhydramine50mg dose given as two 25mg capsules |
| cetirizine | Active comparator | Drug: cetirizine10mg dose given as 1 10mg capsule and 1 placebo capsule |
| desloratadine | Active comparator | Drug: desloratadine5mg dose given as 1 5mg capsule and 1 placebo capsule |
| placebo | Placebo comparator | Drug: placebogiven as 2 placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted
- Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less
- No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study
- No significant medical co-morbidities
- allergy
Key exclusion criteria (2 listed)
- pregnant or breastfeeding females
- unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diphenhydramine | Drug | diphenhydramine |
| cetirizine | Drug | cetirizine |
| desloratadine | Drug | desloratadine |
| placebo | Drug | placebo |
Primary outcome
change in methacholine pc20
Time frame: change from baseline (pre dose) at 2 hours (post dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald W Cockcroft, MD principal investigator
University of Saskatchewan, Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphenhydramine, cetirizine and desloratadine in people with Asthma, run by Don Cockcroft at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in methacholine pc20 (time frame: change from baseline (pre dose) at 2 hours (post dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.